When the blood thinner Pradaxa was released in October of 2010, it was hailed as a safe and convenient alternative to Coumadin for atrial fibrillation patients. Unfortunately, experts have now warned that the drug may cause severe internal bleeding.
Early Pradaxa research was conducted in the RE-LY clinical trials, which were used as a basis for FDA approval. However, some critics now suggest that only certain results of the trials were made public, while other parts showing safety risks were not disclosed.
Within weeks of the FDA’s approval of Pradaxa, further research by MedWatch showed the agency had received more reports of side effects from Pradaxa than 98% of other drugs on the market. Complaints included internal bleeding in the brain, intestines and kidneys, as well as heart attacks.
By the end of March 2011, the FDA had received more than 500 reports of internal bleeding injury or death among Pradaxa patients.
On December 7, 2011, the FDA announced that it would conduct additional Pradaxa research after the drug had more reports of complications than any other drug in 2011; 3,781 side effects and 542 deaths according to USA Today.
A federal judge has now ruled that those who suffered internal bleeding while taking Pradaxa can file lawsuits against the manufacturer. Lawyers are helping those affected file claims and can discuss your case today.
In the months following the FDA warning of health risks, Pradaxa research has continued to question the safety of the drug.
In March of 2012, the Journal of Neurosurgery, examined the case of a patient who had died of internal bleeding more closely. The report explained that, while all blood thinners can cause internal bleeding, most, like Coumadin or Warfarin, have reversal agents that can be used in the case of emergency. Doctors complained that once Pradaxa causes bleeding, there is little they can do to stop it.
In September of 2012, The Journal for The American Medical Association raised concerns over whether the FDA may have rushed approval of certain drugs like Pradaxa, overlooking key side effects such as internal bleeding.
That same month, the University of Pécs in Hungary concluded long-term Pradaxa research which suggested the risks of the drug may outweigh benefits. Researchers found that patients taking the drug after an acute heart condition were three times as likely to have a bleeding event.
The maker of Pradaxa, Boehringer Ingelheim, recently reported that the drug has been prescribed for a total of 1 million patient-years and has been used in over 70 countries. Experts fear thousands of patients may ultimately suffer serious bleeding side effects.
Due to the number of patients expected to file injury claims, Pradaxa lawsuits have been consolidated into a special federal court in Illinois. A lawyer can explain whether you qualify and how long you have to take action.
Before you choose a lawyer, make sure they are qualified for this type of lawsuit and have experience fighting large drug companies. The Drug Resource Center only recommends law firms that specialize in Pradaxa lawsuits.
For more information on the side effects, warnings and legal action related to the drug Pradaxa, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.